Examples of healthcare administrative and claims databases and associated NOAC studies
| Claims database | Design | Study examples | Results |
| CNODES multicentre database | USA and Canada; healthcare data from five Canadian provinces and the USA. | Jun et al
76 n=59 525 | No increase in risk of major bleeding or all-cause mortality was associated with NOACs compared with warfarin in patients with venous thromboembolic events, within the first 90 days of treatment (major bleeding, HR=0.92, 95% CI 0.82 to 1.03; death, HR=0.99, 95% CI 0.84 to 1.16).76 |
| Medicare programme | USA; retrospective healthcare claims database. | Graham et al
54 n=134 414 Graham et al 53 n=118 891 | Dabigatran was associated with a reduced risk of ischaemic stroke, ICH and death but was also associated with an increased risk of major GI bleeding, compared with warfarin in elderly patients with NVAF.54 Treatment with rivaroxaban was associated with a non-significant reduction in thromboembolic stroke compared with dabigatran. However, a significant increase in ICH and major bleeding rates compared with dabigatran was also noted.53 |
| US Truven Health MarketScan | USA; retrospective commercial claims and Medicare supplemental database. | Coleman et al
55 n=22 822 | Rivaroxaban was associated with a significantly lower combined rate of both stroke and ICH compared with warfarin (HR=0.61, 95% CI 0.45 to 0.82). This rate was lower but non-significant for apixaban compared with warfarin.55 |
| National database | Denmark; nationwide registry study linking data from across several Danish administrative registries. | Sindet-Pedersen et al
77 n=12 318 | Rivaroxaban was associated with a similar major bleeding risk and risk of recurrent VTE compared with VKA treatment (major bleeding 2.28% vs 2.10%; recurrent VTE 3.03% vs 3.13%, respectively).77 |
| 1. Danish National Prescription Registry78 1994 | 1. National database including purchase date, ATC code, package size and dose units. | Sørensen et al 56 | In patients receiving dabigatran, an increased risk of thromboembolism (dabigatran 110 mg and 150 mg) and bleeding (dabigatran 110 mg only) was observed if patients had prior use of VKAs, compared with the VKA treatment arm.56 |
| 2. Danish National Patient Register48 1977 | 2. National database including hospital admission and discharge dates, discharge diagnoses (ICD). | Larsen et al 50 | No significant difference was observed between NOACs and warfarin for rates of ischaemic stroke. For apixaban and dabigatran, the risk of death, any bleeding and major bleeding was significantly lower compared with warfarin. Rivaroxaban was associated with similar bleeding and death rates compared with warfarin.50 |
| 3. Danish Civil Registration System79 1968 | 3. National database including age, gender, date of birth, vital and emigration status. | Nielsen et al 49 | When NOACs were used at a reduced dose, no significant difference was observed for the risk of ischaemic stroke/systemic embolism between NOACs and warfarin. Bleeding rates were significantly lower for dabigatran compared with warfarin and similar bleeding rates observed for rivaroxaban and apixaban compared with warfarin.49 |
| Vårdanalysdatabasen | Regional database of Stockholm area of Sweden, which includes data relating to hospitalisations/other healthcare consultations (including primary care and outpatient visits), diagnoses and prescription claims (derived from National Prescribed Drug Register). | Forslund et al
51 n=22 198 Forslund et al 80 n=13 390 | Similar risks of TIA/ischaemic or unspecified stroke/death and severe bleeding were demonstrated for patients with AF treated with NOAC and warfarin (HR=0.94, 95% CI 0.85 to 1.05 and HR=1.02, 95% CI 0.88 to 1.19). Lower risks were associated with NOACs for intracranial bleeding (HR=0.72, 95% CI 0.53 to 0.97) and haemorrhagic stroke (HR=0.56, 95% CI 0.34 to 0.93) compared with warfarin, but a higher risk was observed with NOACs for GI bleeding (HR=1.28, 95% CI 1.04 to 1.59).51 For patients with NVAF receiving OACs, the 1-year crude persistence rates were 85.9% with apixaban, 74.4% with dabigatran, 77.4% for rivaroxaban and 85.0% for warfarin.80 |
| Swedish Patient Register | National database including hospital admission and outpatient visits including diagnoses and procedures (ICD). | Friberg and Oldgren81 n=68 056 | Risks for all-cause stroke and systemic embolism were similar with NOACs and warfarin (HR=1.04, 95% CI 0.91 to 1.19). Significantly lower risks were observed with NOACs for major bleeding (HR=0.85, 95% CI 0.76 to 0.96), ICH (HR=0.60, 95% CI 0.47 to 0.76) and all-cause mortality (HR=0.89, 95% CI 0.81 to 0.96) compared with warfarin. However, a higher risk was observed for GI bleeding in the NOAC group (HR=1.22, 95% CI 1.01 to 1.46).81 |
| Swedish Prescribed Drug Register | National database including details about every dispensed prescription. | ||
| Swedish Cause of Death Register | National database including cause of death. | ||
| Swedish socioeconomic longitudinal integration database for health insurance and labour market studies (LISA) register | National database including demographic information (eg, educational level, occupation, income). |
AF, atrial fibrillation; ATC, Anatomical Therapeutic Chemical Classification; CNODES, Canadian Network for Observational Drug Effect Studies; GI, gastrointestinal; ICD, International Classification of Diseases; ICH, intracranial haemorrhage; NOAC, non-vitamin K antagonist oral anticoagulant; NVAF, non-valvular atrial fibrillation; OAC, oral anticoagulant; TIA, transient ischaemic attack; VKA, vitamin K antagonist; VTE, venous thromboembolism.